Method For Constructing A Blood Glucose Sampling Device

ABSTRACT

A method for constructing a blood glucose sampling device is provided. A housing sized to accommodate a lancet and a removable sensor cartridge is formed. The sensor cartridge includes test strips and cleaning elements. A movable outer grip is defined along a circumference of the housing and is shaped to conformably fit within a hand of a user. A test passage is formed in the outer grip in which one of the test strips and the lancet are aligned.

CROSS-REFERENCE TO RELATED APPLICATION

This non-provisional patent application is a continuation of U.S. patentapplication Ser. No. 12/575,405, filed Oct. 7, 2009, pending; whichclaims priority to under 35 U.S.C. §119(e) to U.S. Provisional PatentApplication Ser. No. 61/195,352, filed Oct. 7, 2008, the disclosure ofwhich is incorporated by reference.

FIELD

This application relates in general to sampling devices and, inparticular, to a blood glucose sampling device.

BACKGROUND

Diabetics, both type I and type II, who take insulin must measure thelevels of their blood glucose at various times to know how much food orinsulin to take to compensate for their present state. For many years,blood glucose has been measured by taking a lancing device from apocket, purse, or testing kit, lancing through the skin of a patient'sfinger into the capillary bed, extracting a small drop of blood onto atest strip, and measuring the blood glucose concentration using anelectronic blood glucose meter or color chart.

Specifically, to make this blood glucose measurement, a fresh test stripis first removed from a carrying case, and inserted into the bloodglucose meter. A lancing device, which has a spring-loaded point tip orlancet, is then employed to prick through the skin into the patient'scapillary bed, usually on a fingertip. Sometimes, particularly when theambient temperature is cool, the finger must be “milked” or manuallysqueezed toward or around the lanced site to get a drop of blood that islarge enough to analyze. This drop of blood is wicked into or placed onthe test strip, where a chemical reaction takes place, which enables themeter to yield a measurement of the blood glucose concentration in thatblood sample.

The step of getting the blood onto or into the test strip usuallyinvolves picking up the meter with a test strip already in place andmoving the tip of the test strip to touch the exposed surface of thedrop of blood on the pricked fingertip. The test strip usually includesa capillary or absorbent material that wicks the blood onto a glucoseoxidase region, where the blood is then analyzed for blood glucoseconcentration.

The resultant blood glucose measurement is displayed on the meter'sdisplay screen, so that the patient can subsequently take insulin or eatfood, as appropriate. Once the analysis of the blood sample is completeand the result displayed, the patient must use a tissue or similarmaterial to remove any excess blood on the fingertip or other site fromwhich the sample was taken. The used test strip is removed from themeter and carefully discarded. Care is taken to avoid touching the endof the strip, which still contains blood. Wiping the end of the stripwith a tissue helps to remove the possibility of unwanted blood stains.

Conventionally, the taking of a blood sample for blood glucosemeasurement involves multiple steps, requires fresh testing supplies andequipment, specifically a lancing device and blood glucose meter. Theproduction can take substantial time to complete for the diabetic. Thesupplies and equipment must be on-hand wherever the diabetic goes.Additionally, blood glucose testing is noticeable by individuals aroundthe patient and is often an awkward or embarrassing procedure tocomplete in public settings due to the drawing of blood, meter usage,and clean up. Therefore, patients are often compelled to postpone theprocess to a more private setting so they are not embarrassed by theobtrusiveness of the process.

Attempts to improve the sampling and testing process self-performed by apatient have been made. For example, U.S. Patent Application PublicationNo. 2008/0077048, to Escutia et al., teaches a body fluid samplingdevice to automate milking of a patient digit to express a sufficientamount of body fluid. The device includes a catalyst device to applypressure to the digit and a footprint. The digit is positioned withinthe catalyst, which directs blood to a sampling site on the digit, andover the footprint. The footprint guides the penetration member to thedigit. However, the patient must remove his digit from the catalyst toclean up any excess blood.

U.S. Pat. No. 7,004,928 and U.S. Patent Application Publication No.2006/0094985 to Aceti et al. teach a monitoring and drug delivery devicethat provides calibration and semi-continuous monitoring. The deviceincludes a carrier having a plurality of microneedles, each coupled witha conduit, and a plurality of microchannels. One of the microneedlespenetrates the skin of a patient and a blood sample is obtained, whichenters the associated microchannel. After the microneedle punctures theskin, the patient must manually wipe any excess blood with a tissue.

Further, U.S. Pat. No. 6,540,675, U.S. Pat. No. 6,923,764, and U.S.Patent Application Publication No. 2004/0202576, also to Aceti et al.,teach an analyte monitor having a plurality of needles each associatedwith a chamber configured to hold a blood sample. The sample iscollected into the chamber by piercing the skin of a patient with theneedle. Once collected, an arm including a detector and light sourcerotates to the chambers to emit a light source. An absorbance of thelight is detected. Once punctured, the patient must manually clean anyexcess blood from the site of the pierced skin.

Therefore, a need remains for a blood glucose sampling device, whichcould be used by patients without having to assemble all the varioussupplies and equipment to accomplish the task of making a blood glucosemeasurement. A blood glucose sampling device that is more discrete wouldallow patients to make blood glucose measurements without theembarrassment of nearby people being aware that the process is takingplace.

SUMMARY

A unitary sampling device impedes venous return from the blood vesselsof the fingertip being tested by built-in pressure points, and impelsblood toward the lancing site so that manual “milking” of the finger isnot needed. The sampling device also locates the point of lancing of thefingertip whereby the resultant drop of blood is formed to touch acapillary defined on a far end of a test strip. The blood travels viathe capillary to a test region covered by an enzyme electrode, includingglucose oxidase and manual matching of the sensor tip to the drop ofblood on the fingertip is not needed. The sampling device also includesa cleaning element for absorbing the residual blood after the completionof testing. Tissue paper is not needed to clean the lanced site.

A further embodiment provides a blood glucose sampling device. A sensorcartridge includes a plurality of blades oriented in a common directionof rotation about a central point. Each blade includes a test striphaving a test region defined radially on a surface of the test stripfrom an outer edge of the central point at a proximal end and acapillary aligned with a distal end of the test region and extending toan outer edge of the blade. Each blade also includes a cleaning elementpositioned adjacent to the test strip in the common direction ofrotation about the central point. The blades are positioned about thecentral point such that the test strip of one blade contacts thecleaning element of another blade. A lancet is affixed to a lancetcartridge and aligned with the capillary formed in the test strip. Ahousing removably encloses the sensor cartridge and lancet cartridge.The housing includes an outer grip surrounding a circumference of thehousing and is movably shaped to conformably fit within a hand of a userbetween a thumb and a finger. The housing also includes a test passageformed in the outer grip through which the test strip and lancet arepositioned.

A further embodiment includes a band attached to a sampling device thatencircles an extremity of a patient, such as a forearm, and includes adeployable lancet to lance the skin at a preferred location on theextremity, self-locating the testing strip capillary at the lancedlocation, and an enclosure that creates suction that enhances theformation of a drop of blood. A mountable blood glucose sampling deviceis provided. The mountable blood glucose sampling device includes asensor cartridge having a plurality of blades oriented in a commondirection of rotation about a central point. Each blade includes a teststrip having a test region defined radially from the central point at aproximal end and a capillary aligned with a distal end of the testregion and extending to an outer edge of the blade. The sensor cartridgealso includes a cleaning element positioned adjacent to the test stripin the common direction of rotation about the central point. The bladesare positioned around the central point such that the test strip of oneblade contacts the cleaning element of another blade. A lancet isaligned with one of the test strips. A housing is shaped to removablyenclose the sensor cartridge and lancet. The housing includes a testpassage formed on a back side of the housing through which the alignedtest strip and lancet are positioned. A mounting band is attached to thehousing and shaped to removably accommodate an extremity of a user. Asuction element is affixed to the back side of the housing and formed tocontact a portion of the extremity.

In yet a further embodiment, a method for constructing a blood glucosesampling device is provided. A housing sized to accommodate a lancet anda removable sensor cartridge is formed. The sensor cartridge includestest strips and cleaning elements. A movable outer grip is defined alonga circumference of the housing and is shaped to conformably fit within ahand of a user. A test passage is formed in the outer grip in which oneof the test strips and the lancet are aligned.

Such devices would encourage patients to make more frequent and timelyblood glucose measurements, thereby enabling them to improve theirresponse time to blood glucose excursions and ultimately the control ormanagement of blood glucose.

Still other embodiments will become readily apparent to those skilled inthe art from the following detailed description, wherein are describedembodiments by way of illustrating the best mode contemplated. As willbe realized, other and different embodiments and its several details arecapable of modifications in various obvious respects, all withoutdeparting from the spirit and the scope. Accordingly, the drawings anddetailed description are to be regarded as illustrative in nature andnot as restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a top plan view showing a sensor cartridge for use with ablood glucose sampling device in accordance with one embodiment.

FIG. 2 is an exploded view showing a blood glucose sampling deviceassembly, including a housing, lancet, and the sensor cartridge of FIG.1.

FIG. 3 is a flow diagram showing, by way of example, a process forobtaining a blood sample using the blood glucose sampling device of FIG.2.

FIG. 4 is a diagram showing, by way of example, a hand holding the bloodglucose sampling device of FIG. 2 with the fingers in an initialposition of a sampling sequence.

FIG. 5 is a diagram showing, by way of example, a hand holding the bloodglucose sampling device of FIG. 2 with the fingers in a testing positionof a sampling sequence.

FIG. 6 is a cross-sectional view of a finger and blood glucose samplingdevice of FIG. 5.

FIG. 7A is a block diagram showing, by way of example, deployment of alancet into a finger.

FIG. 7B is a block diagram showing, by way of example, entry of a sampleinto a capillary.

FIG. 8 is a block diagram showing, by way of example, rotation of acleaning element to an impalement site on a finger.

FIG. 9 is a block diagram showing a hand holding the blood glucosesampling device of FIG. 2, which displays results of a blood sample.

FIG. 10 is a front plan view of a mountable blood glucose samplingdevice.

FIG. 11 is a cross-sectional view of the mountable blood glucosesampling device of FIG. 10.

DETAILED DESCRIPTION

Self-monitoring of blood glucose, such as in diabetes management, can bea tedious and, at times, socially embarrassing process. A blood glucosesampling device with built-in lancing, testing, and cleaning featurescan allow a patient to easily and discreetly obtain blood samples andmeasure the sample's blood glucose level. The blood glucose samplingdevice includes a housing within which a lancet and a sensor cartridgeare positioned. FIG. 1 is a top plan view showing a sensor cartridge 10.The sensor cartridge 10 includes a plurality of blades 11 each having atest strip 12 and a cleaning element 13. The blades 11 are oriented in acommon direction of rotation around and attached at a central point 14.The test strips 12 and cleaning elements 13 are alternately positioned.For example, the test strip of one blade contacts both the correspondingcleaning element for the blade and a cleaning element of anotherneighboring blade.

Each test strip 12 includes an individual test region 15 having enzymeelectrodes located at an inner or proximal end of the test strip 12,nearest to the central point 14. On one surface of the test strip, acapillary is defined inwardly from an outer edge or distal edge of theblade and feeds into the testing region. A lancet (not shown) impalesthe skin of a patient to obtain a blood sample for testing. The lancetis aligned with a capillary in a clean test strip so that the bloodenters the capillary and flows to the testing region. Obtaining a sampleusing the lancet and test strip are further discussed below withreference to FIGS. 7A and 7B.

The cleaning element 13 is positioned adjacent to the test strip toremove and absorb the excess blood from the fingertip after the sensorcapillary has wicked sufficient blood to complete testing. Excess bloodis removed by manually or automatically rotating the sensor cartridge sothat the cleaning element 13 is adjacent to the puncture point aftercompletion of the blood glucose analysis. Rotation can be provided by amotor and the like. The cleaning element 13 can include an absorbentmaterial, such as a fabric or open cell sponge material. Other types ofabsorbent materials are possible. The cleaning element 13 relieves thepatient from the messy and socially intrusive task of wiping off theexcess blood with a facial tissue or equivalent absorptive material.

The sensor cartridge includes a mount opening that is shaped to bereceived by a shaft rotatably provided in the device housing (notshown). The mount opening can be located at the central point of thesensor cartridge, or alternatively, at another point. The mount openingis further described below with reference to FIG. 2. In a furtherembodiment, the mount opening is keyed to ensure locking of the sensorcartridge 10 to the shaft.

The sensor cartridge 10 can be removably enclosed with a housing. FIG. 2is an exploded view showing a blood glucose sampling device assembly,including a housing, lancet, and the sensor cartridge of FIG. 1. Thelancet 23 can be affixed to a lancet cartridge 26 in which a mountopening 31 is formed centrally or off-center. The mount opening 31 isshaped to receive a shaft positioned within the housing 21. The lancet23 can be affixed adjacent to an outer edge of the lancet cartridge 26to allow extension and retraction of the lancet 23. The lancet 23 isspring-loadable or otherwise slidably-oriented to facilitate lancing ofthe fingertip.

In a further embodiment, the lancet cartridge 26 and sensor cartridge 24can be combined to form a single cartridge, the lancet 23 can be affixedto the sensor cartridge 24, or the lancet 23 can be affixed to thehousing 21. The lancet 23 is be aligned with a test strip of the sensorcartridge 24.

In yet a further embodiment, multiple lancets can be included on thesensor cartridge, lancet layer, or affixed to the housing so that eachlancet corresponds with a blade of the sensor cartridge. The patient cansingly use the corresponding blade and lancet.

The housing 21 can be made of materials, including heavy plastic ormetal, and is shaped to enclose the sensor cartridge 24 and lancetcartridge 23. The housing can be opened on one side, which allowsplacement and removal of the sensor cartridge 24 and lancet cartridge23. The open side can be covered with a door pivotably or otherwiseremovably attached to the housing. One or more displays (not shown) canbe affixed to the door or to another side of the housing for providingreadings of the blood samples collected and analyzed by the samplingdevice.

The sensor cartridge 24 and lancet cartridge 23 can be removablypositioned within the housing via a shaft, which forms a cartridge mount27. Specifically, the mount openings in the sensor cartridge 24 andlancet cartridge 23 are placed over the shaft 27 and secured. The shaft27 can be located centrally or off-center within the housing 21. Whenlocated centrally, the shaft 27 is positioned at the central point ofrotation for the sensor cartridge 24. The sensor cartridge 24 can rotatewithin the housing 21 about the central point so that for each test, anew test strip and cleaning strip are respectively aligned in the testpassage during sampling.

The outside of the housing includes an outer grip 25 that is shaped toconformably fit within a hand of a patient. Within the outer grip 25, atest passage 28 is formed to receive a finger, through which the lancetand capillary of the test strip are aligned for obtaining a sample froma patient. An opening of the test passage formed within the outer grip25 is shaped to receive a body part of a patient, such as a finger.

A sensor cartridge actuator 29 and test actuator (not shown) can also beincluded in the outer grip 25. The actuators can include a pushablebutton, toggle, or switch, as well as other mechanisms. The sensorcartridge actuator 29 is located at a distance from the test passage 28around the circumference of the outer grip 25. The placement of thesensor cartridge actuator 29 is further discussed below with referenceto FIGS. 4-8. Upon selection, the sensor cartridge actuator 29 canadvance the sensor cartridge 24 into position within the housing 21 sothat the test strip of a blade is aligned with the lancet in the testpassage 28. The sensor cartridge can be further advanced in the samedirection so that the cleaning element of the blade is aligned in thetest passage 28. The rotation of the sensor cartridge can be directed byselection of the sensor cartridge actuator. For example, in oneembodiment, the test strip is aligned in the test passage upondepression of the sensor cartridge actuator and the cleaning element isaligned upon release of the same sensor cartridge actuator. In a furtherembodiment, the test strip and cleaning element are aligned in the testpassage using separate sensor cartridge actuators. The sensor cartridgeactuator 29 can activate the display or displays affixed to the housing.

The test actuator can also be affixed to the outer grip 25 of thehousing 21 substantially adjacent to the test passage 28. Upon selectionof the test actuator, the lancet is cocked, released, and extendedthrough the test passage into the test passage opening. In one example,the test actuator is a button that cocks and releases the lancet towardsa patient's finger or other body part upon depression. Once extended,the lancet impales the finger that is placed over the test passageopening. Then, the lancet can be retracted upon release of the testbutton. In a further embodiment, the release and retraction of thelancet can be performed upon the selection of separate actuators or uponselection of the same actuator.

Depression of the test actuator requires pushing provided by a testfinger of the patient. The pushing accomplishes milking of the finger,which directs and traps blood in the tip of the test finger so that thetip is engorged with blood during impalement. Deployment of the lancetinto the fingertip may be performed multiple times to acquire enoughblood necessary to complete a blood analysis.

The blood glucose sampling device provides a simple and efficientprocess for obtaining and analyzing a blood sample. FIG. 3 is a flowdiagram showing, by way of example, a process for obtaining a bloodsample using the blood glucose sampling device of FIG. 2. The bloodglucose sampling device is positioned within a patient's hand and a testfinger is identified. The sampling device includes a lancet and a sensorcartridge having a plurality of blades, each including a test strip andcleaning element. Once positioned, a clean test trip within the bloodglucose sampling device is aligned with the lancet in a test passageformed within the sampling device (block 41). The sampling deviceprovides “milking” (block 42) of the test finger so that the fingertipis engorged with blood. “Milking” can occur through manual meansprovided by the patient, by pressure provided by the sampling device, asfurther described below with reference to FIGS. 5 and 6, and by suctionpressure generated by the sampling device, as further described belowwith reference to FIG. 11.

A lancet is deployed (block 43) to pierce the skin of the engorgedfingertip for obtaining a blood sample and then retracted (block 44).The blood sample is collected (block 45) on the test strip aligned withthe lancet. More specifically, the sample enters a capillary formed onthe test strip and travels to a test region covered with enzymeelectrodes. Once collected, a determination (block 46) is made whetherthe sample is large enough for analysis. If not, additional sample bloodmust be obtained through further “milking” (block 42) of the testfinger. However, if sufficiently large, the sample is analyzed todetermine a blood glucose concentration. After the test finger has beenpierced and the sample collected, a cleaning element is aligned (block48) in the test passage to contact and remove any excess bloodremaining. The analysis (block 47) and cleaning (block 48) can occurconcurrently or sequentially.

FIGS. 4 through 8 show the sequence of events that occur using thesampling device for testing blood glucose. FIG. 4 is a block diagram 50showing, by way of example, a hand 52 holding the blood glucose samplingdevice 51 of FIG. 2 with the fingers in an initial position of asampling sequence. The blood glucose sampling device 51 is shaped to fitwithin the hand 52 of a patient, specifically between a finger 54, suchas the pointer finger, and the thumb 53. Other fingers are possible. Thefinger 54 is selected by a patient as the test finger 54, from which ablood sample is obtained. The thumb 53 rests along the outer grip of theblood glucose sampling device on a sensor cartridge actuator (notshown), while the test finger 54 wraps around a circumference of theouter grip, towards a top of the housing. The blood glucose samplingdevice 51 rests along webbing of the hand 52 between the thumb 53 andpointer finger. In a further embodiment, the test finger 54 can includethe thumb 53, while one of the fingers controls the sensor cartridgeactuator.

FIG. 5 is a block diagram 55 showing a hand 57 holding the blood glucosesampling device 56 of FIG. 2 with the fingers 59 in a test position of asampling sequence. The blood glucose sampling device 51 is positionedwithin the patient's hand 57 and a test finger 59 is sequentiallywrapped around an outer grip of the device 56. The test finger 59 restsupon a test actuator (not shown) and a test passage (not shown)adjacently located in the outer grip. Meanwhile, the thumb is positionedover a sensor cartridge actuator, which rotates the sensor cartridge sothat a capillary of clean test strip is aligned with a lancet in thetest passage. Once the blood glucose sampling device is properlypositioned within the patient's hand for testing, tissue pressure iscreated in the proximal portion of the test finger, nearest the palm, bythe housing of the blood glucose sensor device. Due to the pressure,venous return is impeded in that the test finger while arterial bloodcontinues to flow. This causes an engorgement of blood in the fingertipas the finger is wrapped around the blood glucose sampling device andrests upon the test actuator and test passage. An opening of the testpassage formed in the outer grip allows the tip of the test finger tobulge out adjacent to the capillary of the test strip positioned withinthe test passage.

The pressure is created by a protruding of the outer grip into the testfinger. FIG. 6 shows a cross section of a test finger and a bloodglucose sampling device of FIG. 5. The outer grip or portions of theouter grip of the housing can be made from nitinol wire and foam, whichallows the outer grip to contract and expand when pressure is applied.Specifically, to impede venous return, a side of the outer gripcorresponding with the proximal portion of the test finger protrudesoutwards into the test finger based on a squeezing of the blood glucosesampling device sides adjacent to the protruding side. The squeezing canbe performed by a distal end of the test finger, such as the fingertip,and the thumb by pressing the outer grip into the blood glucose samplingdevice. The increased tissue pressure within the test finger generatedby the squeezing effectively prevents venous blood flow past thepressure point while allowing arterial flow. A series of such ribsaccomplishes a sequential milking process.

Once the blood is collected in the tip of the test finger, a lancet canbe deployed to obtain a sample. FIG. 7A is a block diagram 70 showing,by way of example, deployment of a lancet 73 into a test finger 72. Thetest finger 72 of a patient is positioned upon a test actuator (notshown) and over an opening of a test passage 76, while the thumb restsupon a sensor cartridge actuator, as described above with respect toFIG. 5. More specifically, a tip of the test finger enters the housingthrough the opening of the test passage. Meanwhile, the blood glucosesensing device can rest in the webbing between the thumb and pointerfinger.

During testing, a new test strip should be aligned with the lancet tocollect the sample. The patient can select the sensor cartridge actuatorto rotate the sensor cartridge to a new test strip so that thecorresponding capillary is aligned with the lancet in the test passage76. Once aligned, the patient can squeeze the outer grip of the housingto impede venous return of the test finger, as described above withreference to FIG. 6. Thereafter, the patient can select the testactuator, which deploys the lancet to impale the skin of the engorgedfingertip in precisely the correct location to form a sample blooddroplet at the entrance to the capillary. The creation of fingertipengorgement or milking may be further improved by sequentially squeezingthe test finger from proximal to distal using a manual mechanism.

The blood sample is collected on the test strip aligned with the lancet.FIG. 7B is a block diagram 80 showing, by way of example, entry of asample 85 into an blood glucose sampling device 81. A test strip 83 isaligned with a lancet 84 in the test passage. The alignment ensures thatthe sample obtained is located at the entrance of a capillary 85 in thetest strip 83. A test finger 82 of a patient contacts the test strip 83by entering the housing when positioned over the opening of the testpassage. In a further embodiment, the test strip can extend out of thehousing to ensure contact with the test finger. A sample drop of blood85 forms on the test fingertip 82 after the lancet 84 has been removedand enters the blood glucose sampling device through a capillary 86formed in the test strip 83. The blood 85 travels the distance of thecapillary 83 to a test region (not shown) having enzyme electrodes,which analyzes the blood 85 to determine a concentration level ofglucose present.

Immediately after an adequate amount of blood enters the capillary, acleaning element contacts the test finger. FIG. 8 is a block diagram 90showing, by way of example, rotation of a cleaning element 94 to animpalement site 95 on a test finger 92. Once the sample has entered acapillary 96 formed in a test strip 93 of a blood glucose samplingdevice 91, a sensor cartridge 97 can rotate to align a cleaning element94 with the impalement site 95 on the test finger 92. The cleaningelement 94 can absorb any blood 96 remaining on the test finger 92 sothat the test finger is clean once removed from the blood glucosesampling device. The rotation of the sensor cartridge 97 can beactivated upon a release of a sensor cartridge actuator by a patient.

As described above with reference to FIG. 7A, the patient selects thesensor cartridge actuator to first rotate the sensor cartridge so thatthe test strip 93 is aligned with a lancet (not shown) in a test passageprior to or upon impalement. Release of the sensor cartridge actuatoragain rotates the sensor cartridge in the same direction as the firstrotation to align the cleaning element in the test passage afterimpalement. Other mechanisms for rotating the cleaning element on thesensor cartridge are possible, including selecting a actuator, twistinga housing of the blood glucose sampling device, and rotating a knob.

The obtained sample is analyzed and results are determined. FIG. 9 is ablock diagram 100 showing a hand 102 holding the blood glucose samplingdevice 101 of FIG. 2, which displays results of a sample. The bloodglucose sampling device 101 includes a display 103, which can be affixedto a front side to allow visibility by a patient holding the device 101.Other positions of the display on the blood glucose sampling device arepossible. The display provides a reading of the sampling results,including a level of glucose in the patient's blood. Other informationcan be presented within the display, such as a time and date. Thedisplayed results can be recorded and stored on the blood glucosesampling device, or alternatively, discarded.

A further embodiment includes a device mounted on a band, which is wornon an extremity of the body, such as the forearm or calf, to discreetlyobtain and analyze samples, as well as to prevent loss of the device.FIG. 10 shows front view of a mountable blood glucose sampling device110. A housing 115 of the mountable blood glucose sampling device isaffixed to a mounting device 111 to removably attach to an extremity 112of a patient. The housing 115 can be made from plastic or metal;however, other materials are possible. An example of the mounting device111 can include a band, which wraps around the patient's extremity 112,such as a wrist or ankle. Other types of mounting devices, including astrap, belt, or cuff are possible. A front of the mountable bloodglucose sampling device 110 can include a display 113 to presentinformation. Additionally, actuators 114, such as buttons, switches, ortoggles, can be positioned around a circumference of the mountableglucose sampling device 110 to initiate action performed by the device.

The housing 115 of the mounted blood glucose sampling device 110conformably encloses a sensor cartridge and lancet. FIG. 11 is across-sectional view 120 of the mountable blood glucose sampling device130 of FIG. 10. A housing 121 of the mountable blood glucose samplingdevice 130 conformably encloses a sensor cartridge 122, test member 124,and lancet 125. A test passage opening 128 is formed on a back side ofthe mountable device 130 and positioned to contact a patient extremity127. The test passage opening 128 provides a passage in which the lancet125 is aligned. The sensor cartridge 122 includes a plurality of bladesoriented in a common direction of rotation about a central point. Eachblade includes a test strip and a cleaning element. The test stripincludes a test region with enzyme electrodes that is defined radiallyfrom the central point at a proximal end. A capillary is definedinwardly from an outer edge of the test strip and terminates at a distalend of the test region. The cleaning element is positioned adjacent tothe test strip in the common direction of rotation about the centralpoint. The blades are positioned so that the test strip of one bladcontacts the cleaning element of another blade.

The sensor cartridge 122 also includes a mount opening that is formed atthe central point or off-center. The mount opening is shaped to receivea shaft 129 affixed to an inside of the housing 121. Once positioned,the sensor cartridge 122 can rotatably move to align an outer tip of aclean test strip over the test passage opening 128 for obtaining a bloodsample 132 and to align an unused cleaning element over the test passageopening 128 for removing any excess blood. The test member 124 ispivotally positioned above the test strip or cleaning element alignedover the test passage opening 128 and can include a lever. The testmember 124 is attached to the housing 121 via a pivotable attachmentmechanism 131, which can include a fulcrum. In a rest position, the testmember 124 is substantially parallel to the aligned test strip orcleaning element. When selected via an actuator, a proximal end of thetest member pivots down toward a tip of the aligned test strip orcleaning element, and exert pressure on the tip so that contact is madewith the sample 132 once obtained via the lancet 125. The lancet 125 canbe directly affixed to the housing 121 via a bolt, joint or lock, orattached to a mount 133 that is affixed to the housing 121. Other meansand fasteners for affixing the lancet 135 to the housing 121 arepossible. The lancet 125 is located along the test passage at asubstantially perpendicular angle to the sensor cartridge 122 so that anouter edge of the blades in the sensor cartridge 122 can contact thelancet 125. Other angles are possible. The lancet 125 is spring-loadableor otherwise slidably-oriented to facilitate lancing of the extremity127 through the test passage opening 128.

The mountable blood glucose sampling device 130 also includes a suctionmechanism (not shown) for creating a suction with a test site identifiedon the patient's extremity. The suction mechanism can be located withinthe housing or can be affixed to the back side of the housing. Aninternal suction mechanism can include a pump, and an external suctionmechanism can include a suction cup. Other types of suction mechanismsare possible. The suction can aid in the formation of a blood sample onthe skin surface of the test site. In one embodiment, a pushing force onthe mountable blood glucose sampling device 130 can cause air to beexpelled around the perimeter of the skin, which creates a seal. Thesuction is then created by the recoil force of a spring within themountable blood glucose sampling device 130 to pull the skin of theextremity towards the test passage opening 128. The suction provides“milking” so that the extremity is engorged with blood and prepared forimpalement by the lancet 125, which is deployed to pierce the skin ofthe engorged test site and retracted.

Upon lancing the skin, a blood sample is obtained. The sample enters thecapillary of the clean test strip aligned over the test passage opening128 and travels to the test region for analysis. A determination is madewhether the sample is large enough for analysis. If not, additionalblood must be obtained through further “milking” of the test site.However, if sufficiently large, the sample is analyzed to determine ablood glucose concentration. After the sample is collected, the sensorcartridge is rotated so the unused cleaning element is positioned overthe test passage opening 128 to remove any excess blood remaining on thepatient's extremity. The analysis and cleaning can occur concurrently orsequentially.

The above-identified actions can be initiated by actuators 123, 126formed within an outer circumference of the automated sampling devicehousing 121. The actuators 123, 126 can include a cartridge select,lancet deploy, lancet cock, suction, and mode select actuators. Theactuators 123, 126 can include a pushable button, toggle, or switch, aswell as other mechanisms. Selection of the actuators 123, 126 initiatesa specific action performed by the mountable blood glucose samplingdevice 130.

In one example, the actuators 123, 126 are pushable buttons. Thecartridge select button can initiate rotation of the sensor cartridge122 upon depression so that the capillaries of the test strip arepositioned over the test passage opening 128, adjacent to the lancet125, while release initiates further rotation of the sensor cartridge122 to position a tip of the cleaning element over the test passageopening 128. In a further embodiment, rotation of the sensor cartridge122 can be performed by multiple buttons or actuators. The test buttoncan initiate movement of the test member for applying pressure on thetest strip or cleaning element positioned over the test passage 128. Thetest member 124 can be moved via mechanical means or electrical means,which are initiated by the test pressure button. In one embodiment, thetest pressure button is depressed inward, which applies an upwardpressure on a distal end of the test member 124 to pivot a proximal end,nearest the lancet, down toward the tip of the test strip or cleaningelement. When fully pivoted, the proximal end of the test member exertsa downward pressure on the test strip to the initiate contact with thelancet 125 or on the cleaning element to initiate contact with thesample 132.

The lancet cock button can be selected to cock the lancet for deployinginto the skin of the extremity, while the lancet deploy button candeploy the lancet to impale the test site and subsequently, retract thelancet. The suction button can generate pressure necessary to create asuction between the mountable blood glucose sampling device 130 and theskin of the extremity 137. The mode button allows a patient to switchfunctioning and displays provided by the mountable blood glucosesampling device 130. For example, the mountable device 130 can alsoprovide a time, date, and temperature. Other device functions,actuators, and actuator functions are possible.

While the invention has been particularly shown and described asreferenced to the embodiments thereof, those skilled in the art willunderstand that the foregoing and other changes in form and detail maybe made therein without departing from the spirit and scope.

What is claimed is:
 1. A method for constructing a blood glucosesampling device, comprising: forming a housing sized to accommodate alancet and a removable sensor cartridge comprising test strips andcleaning elements; defining a movable outer grip along a circumferenceof the housing that is shaped to conformably fit within a hand of auser; and forming a test passage in the outer grip in which one of thetest strips and the lancet are aligned.
 2. A method according to claim1, further comprising: orienting the test strips in a common directionof rotation about a central point of the sensor cartridge, wherein eachtest strip comprises a test region defined radially from the mountopening at a proximal end and a capillary aligned with a distal end ofthe test region and extending away from the mount opening; alternatelyinterposing the cleaning elements between the test strips in the commondirection of rotation; and aligning the lancet with at least one of thetest strips.
 3. A method according to claim 1, further comprising:forming a cartridge mount on an inside surface of the housing.
 4. Amethod according to claim 1, wherein the outer grip comprises at leastone of nitinol wire and foam.
 5. A method according to claim 1, furthercomprising: affixing a pivoting cover to a substantially open side ofthe housing.
 6. A method according to claim 5, further comprising:providing a display on the cover.
 7. A method according to claim 6,wherein the display provides at least one of blood glucose measurements,time, and date.
 8. A method according to claim 1, further comprising:installing one or more actuators around the outer grip of the housing.9. A method according to claim 8, wherein the actuators each compriseone of a pushable button, toggle, and switch.
 10. A method according toclaim 1, further comprising: affixing a mounting band to the housing.11. A method for constructing a blood glucose sampling device,comprising: building a sensor cartridge comprising a plurality of bladesoriented in a common direction of rotation about a central point,wherein each blade comprises a test strip and a cleaning elementpositioned adjacent to the test strip; and forming a housing sized toaccommodate a lancet and the sensor cartridge, and comprising acartridge mount defined on an inner surface of the housing; and affixinga pivoting cover to a substantially open side of the housing.
 12. Amethod according to claim 11, wherein the lancet is affixed to at leastone of the sensor cartridge, housing, and a lancet cartridge.
 13. Amethod according to claim 12, further comprising: affixing one or morefurther lancets to at least one of the sensor cartridge, the lancetcartridge, and the housing.
 14. A method according to claim 12, furthercomprising: forming a mount opening in each of the sensor cartridge andthe lancet cartridge.
 15. A method according to claim 14, wherein themount openings are formed at least one of centrally and off-center inthe sensor cartridge and the lancet cartridge.
 16. A method according toclaim 14, further comprising: placing the lancet cartridge over thecartridge mount; and placing the sensor cartridge over the cartridgemount.
 17. A method according to claim 11, further comprising:installing an actuator on an outer surface of the housing.
 18. A methodaccording to claim 11, further comprising: forming a test passage in anouter surface of the housing.
 19. A method according to claim 18,wherein the test passage is shaped to receive a user's finger.
 20. Amethod according to claim 11, wherein the housing comprises at least oneof plastic and metal.